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FDA 510(k)

Universa Firm Ureteral Stents and Stent Sets

K-Number: K161236 · 2017-01-27

ApplicantCook Incorporated
Decision Date2017-01-27
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Universa Firm Ureteral Stents and Stent Sets is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-01-27 under approval number K161236. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universa Firm Ureteral Stents and Stent Sets?

Universa Firm Ureteral Stents and Stent Sets is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Cook Incorporated. The 510(k) number is K161236.

When was Universa Firm Ureteral Stents and Stent Sets approved by the FDA?

Universa Firm Ureteral Stents and Stent Sets received FDA 510(k) clearance on 2017-01-27, under approval number K161236.

What company makes Universa Firm Ureteral Stents and Stent Sets?

Universa Firm Ureteral Stents and Stent Sets is manufactured by Cook Incorporated.

What is the FDA product code for Universa Firm Ureteral Stents and Stent Sets?

The FDA product code for Universa Firm Ureteral Stents and Stent Sets is FAD.

Related Clinical Trials

NCT05584280 Systematic Post-Implementation Evaluation of Stents COMPLETED NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT05874934 Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String COMPLETED NCT07495111 Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis RECRUITING NCT07580963 Stent Related Symptoms Defined by Ureteral Stent Symptom Questionnaire in Patients With Image-Informed Ureteral Stent Lengths NOT_YET_RECRUITING NCT06815120 A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent RECRUITING

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Related Devices (Code: FAD)

K163068pAguaMedicina PERSISTENT Structural Hydrogel Ureteral StentQ Urological Corporation K161277ConvertX Nephroureteral Stent SystemBrightwater Medical K160891Ultrathane Endoureterotomy Stent SetCook Incorporated K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTSColoplast Corp. K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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